Immune Monitoring in Sensitized Patients at Risk of Rejection

Kidney Failure Clinical Trial

— PRISM  

Official title:

Immune Monitoring in Sensitized Patients at Risk of Rejection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794817
• Other study ID #: PRISM
• Status: Completed
• Start date: August 20, 2015
• Est. completion date: September 8, 2017

Study information

• Verified date: January 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to test the effect of anti-rejection medications on your immune system

Description:

Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 8, 2017
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18 years or older able to consent

2. No history of HIV, hepatitis C and active hepatitis B infection

3. cPRA = 50%

Exclusion Criteria:

1. Patients on Coumadin

2. Human Leukocyte antigen (HLA) identical donor recipient patients

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune monitoring in sensitized patients at risk of rejection	Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation	2 years
Secondary	Kidney Solid Organ Response Test (kSORT) with pathological findings	Correlation of kSORT with pathological findings on kidney biopsy	2 years